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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06457022
Other study ID # P.T.REC/012/005007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2023
Est. completion date May 5, 2024

Study information

Verified date June 2024
Source AlRyada University for Science & Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

All stroke patients were assessed via isokinetic dynamometer, Montreal cognitive assessment scale (MOCA) and Fugl Myer Upper extremity (FMUE) before and after the treatment program.


Description:

The patients were classified randomly into three equal groups, Study group A (GA) receiving modified constraint induced movement therapy in addition to conventional physical therapy program, Study group B (GB) receiving dual task training in addition to conventional physical therapy program and control group C (GC) receiving only conventional physiotherapy program.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date May 5, 2024
Est. primary completion date March 5, 2024
Accepts healthy volunteers No
Gender All
Age group 55 Years to 65 Years
Eligibility Inclusion Criteria: - Patients with age range between 55 and 65 years old. - The patients were from both genders (males &females). - Patients were of duration of illness between 6 and 12 months. - The patients were scoring 1 &1+ on modified Ashworth scale (mild spasticity). - The patients were of good ability to see and hear. - Consent form was obtained from all participants to approve the study and follow the commands. - All patients were scoring more than 26 on MMSE. All patients were medically stable. Exclusion Criteria: - patients with moderate and sever spasticity. - patients with cognitive disorder due to other cause rather than spasticity. - patients with unstable medical conditions. - patients with previous or recurrent stroke. - patients with respiratory problems. - patients with shoulder dislocation or subluxation or frozen shoulder. - patients with uncontrolled hypertension, diabetes mellitus, unstable angina or heart failure.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Modified Constraint Induced Movement therapy
patient wears a restraint instrument in his unaffected hand, then applying massed practice to his affected upper extremity. The patient wears padded glove in his unaffected upper extremity for restraining the patient from using his unaffected upper extremity for about 3 hours per day including the treatment session and the home program. So, by this way the patient is reinforced to use his affected upper extremity during this period of time to achieve his activities of daily living. Finally, the total time, the patient spends it during the day wearing the glove should be recorded each day.
Dual task training in the form of cognitive - motor task
Verbal fluency: Ask the hemiparetic patient to title many words of specific type as fruits, vegetable or animals. Mental tracking: as the hemiparetic patient to subtract serial 3 between number 90 and 100.
Conventional physiotherapy rehabilitation program
Ultrasound on shoulder. Graduated active exercises for shoulder. Prolonged stretching for spastic muscles

Locations

Country Name City State
Egypt Al Ryada University for Science and Technology Sadat Menoufia

Sponsors (1)

Lead Sponsor Collaborator
Ahmed Alshimy

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biodex isokinetic dynamometer Used to assess muscle strength and function 6 weeks
Primary Montreal cognitive assessment a quick test that is used to examine mild cognitive impairment and early dementia. 6 weeks
Primary Fugl Myer upper extremity a scale used to measure the functional impairment of stroke 6 weeks
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